System for tissue approximation and fixation

ABSTRACT

A system for tissue approximation and fixation is described herein. The devices are advanced in a minimally invasive manner within a patient&#39;s body to create one or several divisions or plications within a hollow body organ. The system comprises a tissue acquisition and folding device and a tissue stapling or fixation device, each of which is used together as a system. The acquisition device is used to approximate tissue regions from within the hollow body organ and the stapling device is advanced through a main lumen defined through the acquisition device and is used to affix the approximated tissue. The stapling device is keyed to maintain its rotational orientation relative to the acquisition device as well as to provide the user positional information of the stapling device. The acquisition device is also configured to provide lateral stability to the stapling device prior to the stapling device being clamped onto tissue.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus andmethods. More particularly, it relates to devices and methods forapproximating portions of a hollow body organ, particularly a stomach,intestine, or other region of the gastrointestinal tract, while affixingthe tissue.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may currently undergo several typesof surgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe gastrointestinal tract. The procedures currently available includelaparoscopic banding, where a device is used to “tie off” or constrict aportion of the stomach, vertical banded gastroplasty (VBG), or a moreinvasive surgical procedure known as a Roux-En-Y gastric bypass toeffect permanent surgical reduction of the stomach's volume andsubsequent bypass of the intestine.

Typically, these stomach reduction procedures are performed surgicallythrough an open incision and staples or sutures are applied externallyto the stomach or hollow body organ. Such procedures can also beperformed laparoscopically, through the use of smaller incisions, orports, through trocars and other specialized devices. In the case oflaparoscopic banding, an adjustable band is placed around the proximalsection of the stomach reaching from the lesser curve of the stomacharound to the greater curve, thereby creating a constriction or “waist”in a vertical manner between the esophagus and the pylorus. During aVBG, a small pouch (approximately 20 cc in volume) is constructed byforming a vertical partition from the gastroesophageal junction tomidway down the lesser curvature of the stomach by externally applyingstaples, and optionally dividing or resecting a portion of the stomach,followed by creation of a stoma at the outlet of the partition toprevent dilation of the outlet channel and restrict intake. In aRoux-En-Y gastric bypass, the stomach is surgically divided into asmaller upper pouch connected to the esophageal inflow, and a lowerportion, detached from the upper pouch but still connected to theintestinal tract for purposes of secreting digestive juices. A resectedportion of the small intestine is then anastomosed using an end-to-sideanastomosis to the upper pouch, thereby bypassing the majority of theintestine and reducing absorption of caloric intake and causing rapid“dumping” of highly caloric or “junk foods”.

Although the outcome of these stomach reduction surgeries leads topatient weight loss because patients are physically forced to eat lessdue to the reduced size of their stomach, several limitations exist dueto the invasiveness of the procedures, including time, use of generalanesthesia, time and pain associated with the healing of the incisions,and other complications attendant to major surgery. In addition, theseprocedures are only available to a small segment of the obese population(morbid obesity, Body Mass Index≧40) due to their complications, leavingpatients who are considered obese or moderately obese with few, if any,interventional options.

In addition to surgical procedures, certain tools exist forapproximating or otherwise securing tissue such as the stapling devicesused in the above-described surgical procedures and others such as inthe treatment of gastroesophageal reflux disease (GERD). These devicesinclude the GIA® device (Gastrointestinal Anastomosis devicemanufactured by Ethicon Endosurgery, Inc. and a similar product byUSSC), and certain clamping and stapling devices as described in U.S.Pat. Nos. 5,403,326; 5,571,116; 5,676,674; 5,897,562; 6,494,888; and6,506,196 for methods and devices for fundoplication of the stomach tothe esophagus for the treatment of gastroesophageal reflux disease(GERD). In addition, certain tools, such as those described in U.S. Pat.Nos. 5,788,715 and 5,947,983, detail an endoscopic suturing device thatis inserted through an endoscope and placed at the site where theesophagus and the stomach meet. Vacuum is then applied to acquire theadjacent tissue, and a series of stitches are placed to create a pleatin the sphincter to reduce the backflow of acid from the stomach upthrough the esophagus. These devices can also be used transorally forthe endoscopic treatment of esophageal varices (dilated blood vesselswithin the wall of the esophagus).

There is a need for improved devices and procedures. In addition,because of the invasiveness of most of the surgeries used to treatobesity and other gastric disorders such as GERD, and the limitedsuccess of others, there remains a need for improved devices and methodsfor more effective, less invasive hollow organ restriction procedures.

BRIEF SUMMARY OF THE INVENTION

A system for tissue approximation and fixation is described which may beused to approximate tissue regions from within a hollow body organ, suchas the stomach, esophageal junction, and other portions of thegastrointestinal tract. Generally, the devices of the system may beadvanced in a minimally invasive manner within a patient's body, e.g.,transorally, endoscopically, percutaneously, etc., to create one orseveral divisions or plications within the hollow body organ. Examplesof placing and/or creating divisions or plications may be seen infurther detail in U.S. Pat. No. 6,558,400; U.S. patent application Ser.No. 10/188,547 filed Jul. 2, 2002; and U.S. patent application Ser. No.10/417,790 filed Apr. 16, 2003, each of which is incorporated herein byreference in its entirety. The system may comprise at least a tissueacquisition and folding device and a tissue stapling or fixation device,each of which may be used together as a single system.

The folder assembly may generally comprise, in part, a pod assemblywhich may be used to initially acquire and approximate the tissue to befolded. The pod assembly may comprise a first pod member and a secondpod member, each of which may be independently articulatable to form afirst compact configuration and a second larger, expanded configuration.Each of the pod members may be connected to respective first and secondactuation rods on the distal end of a yoke member, which connects thepod members to an elongate working body or shaft. The working bodyitself may be comprised of a plurality of aligned link members which areadapted to provide some flexibility to the working body and whichdefines a main lumen throughout a length of the working body as well asthrough the handle connected to a proximal end of the working body.Moreover, the working body may be covered by a sheath or a covering toenhance the lubricity of the shaft as well as to maintain the interiorof the working body clear from body fluids and debris and seal the shaftto allow insufflation of the target organ. Various materials may beutilized for the sheath including various plastics, elastomers, latex,polyurethane, thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®,Pebax®, etc., so long as they are preferably biocompatible.

One or both of the pod members may additionally define a vacuum chamberor opening into which the tissue may be drawn within. The opening of thevacuum chamber may be slotted along a direction parallel to alongitudinal axis of the working body; alternatively, the opening may bedefined a variety of shapes, e.g., oval, elliptical, etc., andfurthermore may be offset such that it is defined transverse to thelongitudinal axis of the working body. Adjacent to and preferablyparallel with the vacuum chamber is a tensioning arm or member, whichmay have a length equal to that of the vacuum chamber. Alternatively, alength of the tensioning member may be less than or greater than that ofvacuum chamber. The distal end of each pod member may have a flexibleand/or atraumatic tip such as a blunt, rounded, or “bullet” tip, madefrom any number of polymers to facilitate the guidance of the podassembly into the hollow body organ without damaging tissue along theway.

A guidewire may optionally be used with the folder assembly duringinitial deployment and positioning within the hollow body organ in amanner similar to a catheter for guiding the pod assembly to apredetermined position. The use of the guidewire may assist in initialplacement of the device transorally, and it can also be exchangedthrough a lumen in the tip of one or both of the pod tips. Both of thefirst and second pod members may each be adapted to pivot on respectivehinge members such that in a first compact configuration, the first andsecond pod members are immediately adjacent to one another. Whendesirably positioned within the hollow body organ, a vacuum force may beapplied within one or both of the pod members such that tissue begins toenter within one or both of the vacuum chambers or openings. To assistin placement of the device, various indicators may be used. Forinstance, one or several indicators may be located directly on thedevice or indicators may be utilized with the device in relation toanatomical structures or landmarks. In one example, an orientationmarker may be placed at a point on the distal portion of the device thatis visible endoscopically and can be adjusted relative to structuressuch as the “z-line” of the gastroesophageal, i.e., the place where achange in color of the tissue from whitish (esophagus) to a salmon color(stomach) occurs delineating what is referred to as the squamocolumnarjunction, i.e., the point where the lining changes from esophageal(squamous) to stomach (columnar). Then, in moving to a second expandedconfiguration, one or both of the first pod member and/or the second podmember may be translated via actuation rods into opposing radialdirections from one another such that the opposing areas of tissue areapproximated to create an overlap region. Once this overlap region hasbeen desirably created, the fixation assembly may be advanced distallythrough the main lumen of the folder assembly and positioned uponexiting the main lumen to become clamped directly over the overlappedtissue. It is also within the scope of this disclosure to actuate thepods simultaneously, serially or singularly where only one fold oftissue is manipulated and fastened.

Vacuum tubes may be routed through the length, or a partial length, ofthe working body for communication with the pod assembly. The proximalends of the vacuum tubes may be connected to one or more vacuum pumps.Furthermore, the vacuum tubes may utilize braided materials, e.g.,stainless steel or superelastic materials such as Nickel-Titanium alloy,integrated throughout to prevent kinking or pinching of the tubes.

The fixation assembly comprises, in part, a manipulatable staplerassembly connected via a flexible shaft to a stapler handle. The staplerassembly itself generally comprises a staple cartridge housing withinwhich one or more staples are housed. A corresponding anvil ispositioned in apposition to the staple cartridge housing and may be usedto provide a staple closure surface when tissue to be affixed isadequately positioned between the staple cartridge housing and theanvil. With the stapler assembly connected at the distal end of aflexible shaft, a handle is connected at the proximal end of the shaft.The handle itself may allow the surgeon or user to hold and manipulatethe fixation assembly while articulating the stapler assembly between anopen and closed configuration. Moreover, the configuration of the handleallows the surgeon or user to actuate the stapler assembly as well asdeploy the staples from the staple cartridge housing.

In use, the fixation assembly may be advanced within the folder assemblymain lumen with the fixation assembly configured in a closedconfiguration. To maintain an orientation, i.e., rotational stability,of the fixation assembly relative to the folder assembly and theapproximated tissue, the fixation assembly may be configured to have ashape which is keyed to a cross-sectional area of the folder assemblymain lumen. The keyed configuration helps to ensure that as the fixationassembly is advanced through the folder assembly, that the staplerassembly is optimally positioned to be clamped over the tissue forfixation.

When the stapler assembly is advanced and has exited the main lumen ofthe working body, the staple cartridge housing may be actuated into anopen configuration when positioned between distally extending armmembers of a yoke to receive the tissue folded between the pod members.The yoke arm members are configured such that when the stapler assemblyis positioned therebetween, the stapler assembly is prevented fromrotating or bending out of alignment for tissue affixation, i.e., thelateral stability of the stapler assembly is maintained relative to theyoke and the tissue. The stapler assembly may then be advanced distallyover the folded tissue and clamped onto the tissue for deploying thestaples. To avoid damaging tissue surrounding the pod assembly, one orseveral insertion indicators may be defined along a portion of flexibleshaft of the fixation assembly, preferably near a proximal end of theshaft, to aid the user in knowing when the stapler assembly may besafely articulated while the fixation assembly is positioned within theworking body, i.e., the longitudinal stability of the stapler assemblyis maintained relative to the folder assembly. The indicators may beconfigured to align with a proximal end of the folder handle tocorrespondingly indicate, e.g., a position of the fixation assemblyrelative to the folder assembly when the stapler assembly may be opened,and/or how far distally the fixation assembly may be advanced relativeto the folder assembly to engage the folded tissue, and when the devicesare in a “safe to clamp” mode (e.g., in position around the tissue).Such positional indicators may utilize mechanical features, such as astop or detent. In addition, the stapler assembly jaws my bespring-loaded open to assist insertion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a tissue folding and fixationassembly which may be advanced within a hollow body organ to reconfigurethe tissue from within.

FIGS. 2A and 2B show side and top views, respectively, of a pod assemblywhich may be used to manipulate tissue.

FIGS. 2C to 2E show cross-sectional side views of rotatable valves whichmay be used control the vacuum force within the device.

FIGS. 3A and 3B show an end view of a pod assembly which has beentranslated with respect to one another while adhering tissue.

FIG. 3C shows an end view of a pod assembly in which a single pod memberhas been actuated with tissue adhered thereto.

FIG. 4 shows a representative illustration of the tissue overlap whichis created by the translated pod assembly.

FIG. 5 shows an example of a cross-sectional side view of the tissueoverlap where a stapler assembly has been articulated and clamped ontothe tissue overlap.

FIG. 6A shows a partial assembly of the handle for the folder assembly.

FIG. 6B shows a detail view of an exploded assembly of anchoring mountsand a proximal portion of an actuation rod assembly.

FIG. 7 shows a side view of an alternative variation on a dual actuatorfolder assembly housing.

FIGS. 8A to 8C show side, end, and perspective views, respectively, of alink which may serve as a transitional link between the folder handleand the working body.

FIGS. 9A to 9C show side, end, and perspective views, respectively, ofone variation of links which may be used to form at least part of theworking body.

FIG. 9D shows an end view of a link having cross-sections of some of thevarious internal lumens which may be routed through the working body.

FIGS. 10A to 10C show side, end, and perspective views, respectively, ofone variation of an end link which may be used as a terminal link of theworking body.

FIG. 11 shows an end view of a link with the fixation assemblypositioned within for advancement through the main lumen of the workingbody while maintaining a consistent orientation.

FIGS. 12A to 12C show top, cross-sectional side, and perspective views,respectively, of one variation of a yoke member.

FIGS. 12D and 12E show front and rear end views, respectively, of theyoke member of FIGS. 12A to 12C.

FIG. 13A shows a top view of a stapler cartridge assembly positionedbetween the arm members of the yoke.

FIGS. 13B and 13C show variations of the stapler assembly positionedbetween the yoke having varied open regions.

FIGS. 14A to 14C show top, end, and side views, respectively, of analternative angled hinge member for use with a pod member.

FIGS. 15A to 15C show top and perspective views, respectively, of avariation of a yoke and hinge assembly.

FIGS. 16A to 16C show perspective views of a variation on a hinge devicewhich may be adapted to angle a pod assembly in an offset configuration.

FIG. 17A shows a perspective view of one variation of the pod assemblywith the top cover and optional basket insert removed for clarity.

FIG. 17B shows a perspective view of one variation of a top cover whichmay be used with the pod assembly.

FIG. 17C shows a cross-sectional view of an optional basket insertpositioned within a vacuum chamber and a top cover secured over thechamber.

FIGS. 17D and 17E show another variation of FIGS. 17B and 17C,respectively, where the top cover and/or pod member may have serrations.

FIGS. 18A to 18D show side, end, bottom, and perspective views,respectively, of an optional basket insert which may be placed withinthe vacuum chamber of the pod assembly.

FIGS. 19A and 19B show side and top views, respectively, of anothervariation of the pod assembly where an angled pod assembly may bemounted on a distal end of the working body.

FIGS. 19C and 19D show rear and front views, respectively, of the podmembers and the staple assembly of FIGS. 19A and 19B.

FIGS. 20A and 20B show side views of a variation of the stapler assemblyin clamped and opened configurations, respectively.

FIGS. 21A and 21B show side views of a variation of a cam member whichmay be used to urge the stapler assembly open and close.

FIGS. 22A to 22C show cross-sectional side, front, and top views,respectively, of one variation of stapler assembly.

FIG. 22D shows a top view of the anvil of the stapler assembly.

FIG. 22E shows a side view of another variation of a stapler assemblyhaving serrations defined along its clamping surfaces.

FIG. 23A shows a top view of one variation of staple pushers positionedover corresponding staples.

FIG. 23B shows a detailed perspective view of one example of a staplepusher.

FIG. 23C shows a perspective view of one example of a wedge which may beconfigured to slide within the cartridge housing.

FIGS. 24A and 24B show cross-sectional side views of one variation of astapler handle and its associated controls.

FIGS. 25A and 25B show perspective views of another variation of theapproximation device having an actively or passively curved workingbody.

FIG. 25C shows a detail view of the actuation handle of the device inFIGS. 25A and 25B.

FIGS. 25D and 25E show perspective and end views, respectively, of avariation of an end cap or seal which may be used to cap the handle ofFIG. 25C.

FIG. 26 shows a perspective view of one variation in which an endoscopecan be retroflexed to view the results or progress of the tissueapproximation and/or fixation.

FIG. 27 shows a portion of a flexible shaft of a stapler assembly withseveral insertion indicators positioned through the main lumen of thehandle of the folder assembly.

DETAILED DESCRIPTION OF THE INVENTION

A system for tissue approximation and fixation is described which may beutilized for approximating tissue regions from within a hollow bodyorgan, such as the stomach, esophageal junction, and other portions ofthe gastrointestinal tract. The system may be advanced within a bodythrough a variety of methods, e.g., transorally, transanally,endoscopically, percutaneously, etc., to create one or several divisionsor plications within the hollow body organ. At least two devices may beutilized as part of the system, a tissue acquisition and folding systemand a tissue stapling or fixation system, although it is contemplatedthat both devices can be integrated into a single mechanism. Each ofthese devices may be configured to efficiently operate with one anotherto provide optimal methods and devices for at least acquiring,approximating, and stapling regions of tissue from within the hollowbody organ in a minimally invasive manner.

Turning now to the figures, the system will first be described generallyin which one variation of system 10 is shown in FIG. 1, whichillustrates a perspective view of folder assembly 12 and fixationassembly 14. Folder assembly 12, which is described below in greaterdetail, may be comprised generally of pod assembly 16, which may be usedto initially acquire and approximate the tissue to be folded. Podassembly 16 may have a first pod member 18 and a second pod member 20,each of which may be independently articulatable to form a first compactconfiguration and a second larger, expanded configuration. Each of firstand second pod members 18, 20 may be connected to respective first andsecond actuation rods 22, 24 on the distal end of a yoke member 26, asdescribed in further detail below.

Pod assembly 16 may be located at the distal end of working body 28which may be configured as a flexible shaft having one or several lumensdefined through the length of the working body 28. The working body 28may be covered by a sheath or covering 30 to enhance the lubricity ofthe shaft as well as to maintain the interior of the body 28 clear frombody fluids and debris and provide a seal to allow insufflation of thetarget organ. Various materials may be utilized for sheath 30 includingvarious plastics, elastomers, latex, polyurethane, thermoplastics, e.g.,PTFE, FEP, silicone, PVC, Tecoflex®, Pebax®, etc., so long as they arepreferably biocompatible.

A number of vacuum tubes 32 may also be routed through the length, or apartial length, of the working body 28 to pod assembly 16. The figureshows vacuum tubes 32 entering the working body 28 at its proximal end.Alternatively, vacuum tubes 32 may enter working body 28 at some distalpoint along the length of body 28 or vacuum tubes 32 may enter workingbody 28 through handle 34. In either case, vacuum tubes 32 may bepositioned within one or several lumens defined through working body 28and placed in fluid communication with respective first and second podmembers 18, 20 to facilitate in vacuum actuation of tissue, as furtherdescribed below. The proximal ends of vacuum tubes 32 may be connectedto one or more vacuum pumps (not shown). Furthermore, vacuum tubes 32may utilize braided materials, e.g., stainless steel, superelasticmaterials such as Nickel-Titanium alloy, integrated throughout toprevent kinking or pinching of the tubes 32. Such vacuum tubes 32 mayalso accommodate insertion of a snare or grasper type device that can beinserted once tissue is acquired to mechanically grasp the invaginatedtissue, depending on the type of tissue manipulation desired. An exampleof a “gooseneck” snare by Microvena, Inc. which may be used with thevacuum tubes 32 is described in further detail in U.S. Pat. No.5,171,233, which is incorporated herein by reference in its entirety.

The proximal end of working body 28 is operatively connected to handle34. Also connected to handle 34 are first and second actuators 36, 38which may be used to actuate first and second pod members 18, 20,respectively, from the first compact configuration to the second larger,expanded configuration. Each actuator 36, 38 may be actuatedindividually to control a corresponding pod member independently of theother pod member or may be actuated simultaneously, as described laterherein. Main lumen 40 may be defined throughout the length of workingbody 28 and through handle 34 such that fixation assembly 14 may beadvanced and withdrawn through the folder assembly 12. Fixation assembly14 comprises, in part, stapler assembly 42 connected via flexible shaft48 to a stapler handle 50. Stapler assembly 42 generally comprisesstaple cartridge 44, within which one or more staples are housed.Stapler assembly 42 may also have an optional tapered distal end tofacilitate insertion of the device into or past tissue, as described infurther detail below. Anvil 46 is in apposition to staple cartridge 44and is used to provide a staple closure surface when tissue to beaffixed is adequately positioned between staple cartridge 44 and anvil46. With stapler assembly 42 connected at the distal end of flexibleshaft 48, handle 50 is connected at the proximal end of shaft 48. Handle50 may generally comprise a housing and grip 52 in apposition toactuation handle 54. Handle 50 allows for the surgeon or user to holdand manipulate fixation assembly 14 with grip 52 while articulatingstapler assembly 42 between an open and close configuration viaactuation handle 54. Moreover, the configuration of handle 50 allows thesurgeon or user to articulate stapler assembly 42.

When fixation assembly 14 is advanced within folder assembly 12, staplerassembly 42 is preferably in a closed configuration. When staplerassembly 42 has exited working body 28, staple cartridge 44 may bearticulated into an open configuration when positioned between yoke 26to receive the tissue folded between pod members 18, 20. Staplerassembly 42 may then be advanced distally over the folded tissue andclamped close over the tissue for deploying the staples. To avoiddamaging tissue surrounding pod assembly 16 and to facilitate properstapling, one or several insertion indicator(s) 56 may be defined alonga portion of flexible shaft 48 preferably near a proximal end of shaft48, to aid the user in knowing when stapler assembly 42 may be safelyarticulated while fixation assembly 14 is positioned within working body28. Indicators 56 may be configured to align with a proximal end offolder handle 34 to correspondingly indicate, e.g., a position offixation assembly 14 relative to folder assembly 10 when staplerassembly 42 may be opened, and/or how far distally fixation assembly 14may be advanced relative to folder assembly 10 to engage the foldedtissue, etc. In addition to visual indicators, a mechanical indication,such as a stop or detent may be employed to give the operator a tactileindication of “safe to open” and “safe to clamp” device positions.

A brief description of the pod assembly 16 will be given in order todescribe how the tissue may be manipulated by the devices describedherein. A more detailed description will be given below. Side and topviews of one variation of pod assembly 16 is shown in FIGS. 2A and 2B,respectively. Pod members 18, 20 may each be comprised of a vacuumchamber or opening 60 into which tissue may be drawn therewithin. Avacuum tube 76 may be seen in FIG. 2A leading to first pod member 18.The opening of vacuum chamber 60 may be slotted along a directionparallel to a longitudinal axis of the working body 28, or may betransverse to the parallel axis; alternatively, the opening may bedefined a variety of shapes, e.g., oval, elliptical, etc. Adjacent toand preferably parallel with vacuum chamber 60 is tensioning arm ormember 62, which may have a length equal to that of vacuum chamber 60.Alternatively, a length of tensioning member 62 may be less than orgreater than that of vacuum chamber 60. The distal end of each podmember may have a flexible and/or atraumatic tip 64, 66 made from anynumber of polymers to facilitate the guidance of pod assembly 16 intothe hollow body organ without damaging tissue along the way.

A guidewire may optionally be used with the folder assembly 12 duringinitial deployment and positioning within the hollow body organ in amanner similar to a catheter for guiding pod assembly 16 to apredetermined position. Accordingly, an optional guidewire lumen may bedefined in one or both atraumatic tips 64, 66; as seen in tip 64,guidewire lumen 68 may be defined therein with guidewire 80 extendingthrough from proximal guidewire opening 70 to distal guidewire opening78. Proximal and distal guidewire openings 70, 78, respectively, mayboth be defined on, e.g., atraumatic tip 64, to enable exchange of theguidewire through one or both tips; however, guidewire openings 70, 78may also be defined on other regions of pod members 18, 20 dependingupon the type of exchange capability desired.

Both first and second pod members 18, 20 may each be adapted to pivot onrespective hinge members 72, 74 such that in a first compactconfiguration, first and second pod members 18, 20 may be immediatelyadjacent to one another. As shown, first pod member 18 has acorresponding tensioning member 62 aligned adjacent to member 18 andsecond pod member 20 has a corresponding tensioning member 90 alsoaligned adjacent to member 20. In moving to a second expandedconfiguration, pod member 18 with tensioning member 62 and pod member 20with tensioning member 90 may be translated via actuation rods 22 intoopposing radial directions from one another relative to yoke 26, asshown in FIG. 2B.

The vacuum force which may be used to draw in the tissue may becontrolled through a number of various methods. One variation isillustrated in FIGS. 2C to 2E, which show how valves 82 may beintegrated into handle 34 for controlling the vacuum force. As seen inthe cross-sectional side view of FIG. 2C, valve 82 may be configured torotate and align such that vacuum lumen 84 comes into fluidcommunication with lumen 86, which leads to working body 28. Vacuumlumen 84 may be connected to a vacuum control unit (not shown), e.g., astandard luer assembly (QOSINA, model # 99720), to allow for air to bedrawn through lumen 86 and create the vacuum at the distally-located podmembers. FIG. 2D shows how valve 82 may be rotated by some degree, e.g.,45° relative to a longitudinal axis of handle 34, such that the vacuumforce is no longer in fluid communication with lumen 86. FIG. 2E showshow valve 82 may be further rotated, e.g., 90° relative to alongitudinal axis of handle 34, such that lumen 86 is in fluidcommunication with venting lumen 88 to allow for venting of theassembly. A second valve, as shown, may be integrated in handle 34 toallow for the independent control of the vacuum force in the second podmember. Each of the vacuum lumens 84 may be fluidly connected to acommon or independent vacuum pump. Moreover, rather than having twoindependently controllable valves 82, a single valve 82 may be utilizedto control the vacuum force in both pod members, depending upon thedesired results. The above variations are intended to be illustrativeand are not intended to be limiting in their scope of the disclosure inthe various possible configurations and methods available forcontrolling the vacuum force.

FIGS. 3A and 3B show the movement of pod members 18, 20 relative to oneanother in reconfiguring the surrounding tissue. FIG. 3A shows an endview of pod members 18, 20 which have been advanced while in a closedconfiguration into, e.g., a stomach, and positioned adjacent to a regionof interior tissue to be reconfigured. When desirably positioned, avacuum force may be applied within one or both pod members 18, 20 suchthat tissue begins to enter within one or both of the vacuum chambers oropenings 60, 92.

The different linings of the stomach, which include the mucosal layerMUC, muscular layer ML, and serosal layer SL, are shown incross-section. The vacuum force may be applied such that at least themucosal layer MUC of opposing portions of tissue, e.g., an anterior wallAW and posterior wall PW, are drawn into vacuum chambers 60, 92 and thetissue is sufficiently adhered to the pod members 18, 20. While thevacuum force is applied, pod members 18, 20 may be translated away fromone another in opposing direction such that the adhered tissue is drawnbetween each pod member 18, 20 and respective tensioning member 62, 90such that at least two adjacent folds of tissue are created to form anoverlap region of tissue, as shown in FIG. 3B. Alternatively, ratherthan having both pod members 18, 20 move opposite to one another, onepod member may be held stationary while the other pod member istranslated radially. In addition, it may be desirable to acquire tissueand translate a first pod, and subsequently acquire tissue and translatea second pod as a separate step to enhance tissue acquisition andpositioning. After the tissue has been acquired through any of themethods described above, the device may be curved or manipulated, asdescribed in further detail below. The tissue may then be affixedthrough one of the methods as described herein.

Similarly, it may be desirable to actuate only one pod and tensioningmember to acquire a single, longitudinal fold, for use in treatmentssuch as GERD or to exclude certain portions of the wall of the bodyorgan. Examples of other treatments are described in further detail inco-pending U.S. patent application Ser. No. 10/417,790, which has beenincorporated by reference above. Accordingly, similar to the tissueacquisition in FIG. 3B, FIG. 3C shows how the device may be utilized foracquiring and tensioning a single layer of tissue. In such anacquisition, the vacuum force may be simply shut or turned off in one ofthe pod members, in this case, pod member 18 while the vacuum force inpod member 20 may remain activated.

FIG. 4 shows a representative illustration of the tissue overlap whichis created by the devices, as described herein. The devices are removedfor clarity to better illustrate the tissue overlap formation. FIG. 5shows an example of a cross-sectional side view of tissue overlap 100where staple cartridge 44 and anvil 46 have been articulated and clampedonto overlap 100 for stapling. When the tissue overlap 100 is created byfolder assembly 12, overlap 100 preferably includes an overlap of atleast the muscular layer ML and serosal layer SL to ensure a secureanchoring platform for the staples or fasteners to maintain thedurability of the tissue overlap 100. A more detailed discussion may befound in U.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002and entitled “Method And Device For Use In Tissue Approximation AndFixation”, which is incorporated herein by reference in its entirety.

Folder Assembly

Folder assembly 12 may typically comprise a handle 34 at a proximal endof the assembly 12, as described above. Handle 34 may comprise housing110 which may enclose a pod actuation assembly within. FIG. 6A shows apartial assembly of handle 34 to illustrate the internal mechanisms. Asdescribed above, first actuator 36 may be used to manipulate first podmember 18 from a first configuration to a second configuration. Podmanipulation may be achieved, in part, by having first actuator 36connected via shaft 112 to transmit a torquing force to threadedcarriage shaft 114. The carriage shaft 114 is preferably free-floating,i.e., can translate longitudinally inside the shaft 112. Proximal mount116 may be free to rotate about the carriage shaft 114, but it ispreferably constrained to inhibit translation of mount 116 relative tothe carriage shaft 114. Distal mount 118 may be slidingly positionedover carriage shaft 114, typically by a threaded connection. Thisthreaded connection maintains a fixed relative distance between themounts so that the mounts and the carriage shaft 114 may translatelongitudinally as a unit. Proximal mount 116 and distal mount 118 may beanchored to the proximal ends of the actuation rod and tubing member,which houses the actuation rod, as described further below. Each mount116, 118 and shaft 112 may be configured to be free-floating, i.e.,translate longitudinally unconstrained, inside of shaft 112 within firstactuation channel 120 to accommodate the lateral movement of workingbody 28 and the subsequent translational movement of the proximal endsof actuation rods within housing 110. Stop 144, e.g., a ring or shoulderdefined upon shaft 114, may be positioned proximally of mount 116 toprevent the longitudinal movement of mount 116 along shaft 114. Mounts116, 118, however, may be configured to maintain a fixed distancerelative to one another when longitudinally translated as a unit.Corresponding mounts may be configured to translate along a second shaft(not shown) within second actuation channel 122 for a second actuationrod. Mounts 116, 118 may thus translate as a unit until actuator 36 isrotated.

The handle mechanism 34 helps to ensure that relative or unwantedmovement of the pods during flexing of the shaft of the folder inminimized or eliminated. Additionally, tubes 136, as further describedbelow, function so that the shaft of the device is not loaded duringactuation. These tubes 136 help to support the actuation load, but stillallow sufficient shaft flexibility.

As shown in FIG. 6B, which is a detail view of an exploded assembly ofmounts 116, 118 and their corresponding actuation rod assembly. Proximalmount 116 may have a rod anchoring region 130 defined along one side anddistal mount 118 may have tubing anchoring region 132 defined along oneside and collinearly with rod anchoring region 130. Actuation rod 140may be slidingly positioned within tubing member 136 and configured toslide longitudinally therewithin when translated relative to tubingmember 136 for actuating a pod member. Actuation rod 140 may be anchoredto proximal mount 116 by securely positioning actuation rod anchor 142within anchoring region 130. Likewise, tubing member 136 may be anchoredto distal mount 118 by positioning tubing anchor 138 within tubinganchoring region 132. Each mount 116, 118 may have collinearly definedopenings 134 to accommodate rod tubing 136 and actuation rod 140 whenthey are secured within anchoring regions 130, 132. As actuator 36 isrotated, carriage shaft 114 is rotated about its longitudinal axis tourge mount 118 towards or away from mount 116, as shown by the arrows,depending upon which direction carriage shaft 114 is rotated. Whenmounts 116, 118 are urged towards one another, actuation rod 140 isforced to slide distally within and relative to tubing 136 to urge thepod member, e.g., into its expanded configuration. Similarly, whenmounts 116, 118 are urged away from one another, actuation rod 140 isforced to slide proximally within and relative to tubing 136 to urge thepod member, e.g., into its compact configuration.

As further seen in FIG. 6A, main lumen 40 may be defined through alength of housing 110 to accommodate insertion of the fixation assembly14 therethrough. The proximal opening 128 of lumen 40 may be gasketed toallow for the insufflation of the hollow body organ using the device aswell as to prevent the leakage of bodily fluids and particles. Distalopening 124 may likewise be gasketed and is further configured to accepta proximal end of working body 28. The individual links 126 of onevariation of the proximal end of working body 28 are shown in the figureto illustrate an example of the mating between working body 28 andhousing 110.

An alternative variation on the folder assembly housing is shown in dualactuator assembly 150 in FIG. 7. In this variation, a side view ofhousing 152 is seen in which a single actuator or lever 158 may beutilized to manipulate both pod members simultaneously. Lever 158 may beconfigured to rotate about pivot 160 to urge actuation link 162 totranslate within actuation slot 164 to simultaneously manipulate bothpod members rather than having two or more separate controls. Theproximal end of working body 154 may be seen connected to housing 152and vacuum tube 156 may be seen leading into working body 154 forcommunication with the folder assembly.

When lever 158 is depressed, actuation link 162 translates proximallinkage 155 within actuation slot 164. Proximal linkage 155 is free torotate about a pivot during flexure of the working body 154 and actuatesproximal blocks 153 to slide longitudinally within channels 151, whichare defined through housing 152. A spring or biased element 168 may bepositioned within slot 164 to place a biasing force on link 162 andlever 158 such that the assembly maintains a neutral or fixedorientation, if desired. Proximal blocks 153 are connected to actuationrods 157 which may extend distally through distal blocks 159 and furtherinto working body 154. Distal blocks 159 may be pivotally connected todistal linkage 163, which may be pivotally affixed to housing 152 viapivot 166 while allowing distal blocks 159 to translate within channels151. Tubing members 161 may be configured to allow passage of actuationrods 157 therethrough while remaining connected to distal blocks 159.Although the specific configuration of this variation is shown anddescribed, this is not intended to be limiting and is illustrative ofone variation of a handle which allows for single activation and tunablemechanical advantage.

The working body 28, which extends between the handle and the podassembly located at the distal end of the working body 28, may becomprised of a plurality of links or knuckles generally cylindrical inshape and positioned adjacently to one another, as shown and describedabove in FIG. 6A. A transition link or knuckle 170 is shown in FIGS. 8Ato 8C, which show side, end, and perspective views, respectively, of alink which may serve as a transitional link between the handle and thelength of the working body 28. As seen in the side view of FIG. 8A,transition link 170 may have a proximally located cylindrically-shapedflange 172 with a diameter greater than a diameter of the body portion176. Flange 172 may serve to help anchor the working body 28 to thehandle by fitting within a cavity defined in the handle and shaped toreceive flange 172. A transition portion 174 may taper a region of thelink 170 down to body portion 176. The end view in FIG. 8B shows mainlumen 178 defined through the length of link 170. Main lumen 178 may beshaped with parallel sides opposite to one another to allow fixationassembly therethrough in a specified configuration, as described belowin further detail.

Although the transition link 170 is shown to be generally cylindrical inshape, it may alternatively be configured in a variety of shapes, e.g.,ovular, elliptical, etc. Transition link 170 may also range in diameter,e.g., 0.75 in. (about 1.90 cm), so long as it is wide enough toaccommodate the insertion of fixation assembly 14 therethrough yet smallenough to be inserted into the body, e.g., through the esophagus. Link170 may also range in length, e.g., 1.125 in. (about 2.85 cm), dependingupon the desired design characteristics. Moreover, transition link 170may be made from a variety of materials, e.g., metals, plastics, etc.,so long as it is biocompatible. For example, transition link 170 may bemade from stainless steel, nickel-titanium alloys, or it may be moldedfrom plastics and thermoplastics, e.g., polycarbonate resins such asMakrolon® (Bayer Aktiengesellschaft, Germany).

FIGS. 9A to 9C show side, end, and perspective views, respectively, ofan example of a knuckle or link 180 which may be used to form at leastpart of the working body 28. This link variation 180 may be made from amaterial similar to that of transition link 170. It may also range indiameter, e.g., 0.69 in. (about 1.75 cm), so long as link 180 is wideenough to accommodate the insertion of fixation assembly 14 therethroughyet small enough to be inserted into the body, as above. Lumen 182 maybe configured such that it is keyed to allow fixation assembly 14 topass through in a specified configuration; thus, in this particularvariation, lumen 182 is shown as having straight walls 196, which may beparallel and opposite to one another. Link 180 may also define one ormore routing channels 184 around the circumference of the link 180 toallow for the routing of various wires or tubes therethrough along alength of working body 28. Link 180 shows a variation in which tworouting channels 184 may be defined on opposing sides around thecircumference. As further seen in FIG. 9A, link 180 may further defineperipherally located actuator rod lumens 196 and additional routinglumens 188 in link 180 outside of lumen 182. This variation shows atleast two of each lumen 186, 188 defined on opposing sides of link 180,although they may be defined elsewhere around link 180 in othervariations depending upon the number of lumens desired as well asspacing considerations.

FIG. 9B shows a side view of link 180 having least two protrusions 190extending from a first surface 192 on either side of the periphery oflink 180. Protrusions 190 may extend from first surface 192 at adistance, e.g., 0.040 in. (about 0.10 cm), so that when multiple linksare aligned with one another, protrusions 190 abut the second surface194 of an adjacent link, as shown in FIG. 9C. When multiple links arealigned, lumen 182, as well as actuator rod lumen 186 and additionalrouting lumen 188 may be aligned with adjacent links to form the overallmain lumen 40 and actuator rod lumen, as described above. Alternatively,overall flexibility of the device may be achieved by a single structurethat contains axial slots along its length, such as that shown in U.S.Pat. No. 5,685,868, which is incorporated herein by reference in itsentirety. Similarly, the working body may be formed of a single piece,flexible component, such as a polymer extrusion and/or multi-lumenco-extruded design, a braid, or other such known materials.

FIG. 9D shows an end view of link 180 in one variation where actuationrod 198 is routed through actuator tubing member 202 and both may bedisposed within actuator rod lumen 186 such that both extend through alength of working body 28. Vacuum tubes 200 may also be positionedwithin routing channels 184 and the entire assembly may be covered bysheath or lining 204, which may extend along at least a portion ofworking body 28, and preferably over the entire length of working body28. Sheath or lining 204, as mentioned above, may be used to enhance thelubricity of the working body 28 as well as to maintain the interior ofthe body 28 clear from body fluids and debris and to provide sealing toenable insufflation of the target area. Various materials may beutilized for sheath 204 including various plastics, elastomers, latex,polyurethane, thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®,Pebax®, etc., so long as they are preferably biocompatible. Moreover,sheath 204 may also utilize braided materials integrated throughout toincrease tensile, compressive, and/or torsional strengths of sheath 204as well as to provide for resistance against kinking or pinching betweenindividual links or when working body 28 is flexed.

FIGS. 10A to 10C show side, end, and perspective views, respectively, ofone variation of end link 210, which may be utilized as the terminal orfinal link of working body 28. End link 210, much like links 180, maydefine a keyed lumen 212, routing lumens 214, and actuator rod lumen218. Lumen 216 may also be defined and it may be counterbored toaccommodate a mechanical fastener for connecting the yoke member. As theterminal link, actuator tubing member 202 may be terminated and attachedto end link 210 at lumen 218 while allowing the actuator rod to extendthrough and beyond lumen 218 for attachment to the pod assembly. Sideand perspective views in FIGS. 10B and 10C further show detent 222,which may be defined along the end surface of link 210 for receivingand/or engaging the yoke member. Moreover, end link 210 may be made fromthe same or similar materials as described above for the other links.However, end link 210 is preferably made from a material such as ametal, e.g., stainless steel, or polycarbonate, which may withstandforces generated during pod and tissue manipulation. The end link 210,or a similar or additional link, may also be used to terminate anycovering placed over the working body 28 as heretofor described in FIG.9D.

FIG. 11 shows an end view of link 180 with staple cartridge 44 and anvil46 of fixation assembly 14 positioned within lumen 182 for advancementthrough working body 28. As seen, lumen 182 may be configured such thatit is keyed to allow fixation assembly 14 to pass through in a specifiedorientation. Walls 196, which may be parallel and opposite to oneanother, may thus be sized and configured to prevent fixation assembly14 from rotating about its own longitudinal axis within lumen 182 duringadvancement and deployment from the main lumen. Maintaining fixationassembly 14 in a predetermined orientation relative to working body 28and pod assembly 16 also helps to ensure that when staple cartridge 44and/or anvil 46 are actuated to open for clamping over folded tissue, aknown orientation of fixation assembly 14 relative to the folded tissueis maintained for tissue fixation. Other configurations for keying lumen182 to fixation assembly 14 may be available in other variations; theshape of lumen 182 and the cross-sectional shape of fixation assembly 14are not intended to be limiting but are merely illustrative of onepossibility of creating and/or configuring a keyed orientation betweenthe two assemblies.

A yoke member may be positioned at the terminal end of working body 28for holding and maintaining pod assembly 16. FIGS. 12A to 12C show top,cross-sectional side, and perspective views, respectively, of yoke 230.Generally, yoke 230 may be comprised of first arm member 232 and secondarm member 234 extending in parallel to one another from a base member242, which may be attached via proximal surface 244 to end link 210 ofworking body 28. Yoke 230 may terminate at each arm member 232, 234 infirst and second pivot regions 236, 238, respectively, about which thepod assembly 16 may be manipulated. First and second arm members 232,234 may further extend longitudinally with an overall length of about,e.g., 2 in. (about 5 cm), to create open region 240 between the armmembers 232, 234. First and second arm members 232, 234 may also betapered along their lengths to facilitate insertion of yoke 230 within atissue region. The opposing sides of each arm member 232, 234, which inpart defines open region 240, may be parallel to one another and arespaced apart, e.g., at 0.40 in. (about 1.0 cm), to provide clearance forstapler assembly 42 to be advanced therethrough. Furthermore, the opensides of region 240 may provide adequate clearance for stapler assembly42 to be opened for advancement over tissue to be affixed while armmembers 232, 234 help to maintain the orientation of stapler assembly 42relative to yoke 230 and working body 28.

The actuation rods for manipulating pod assembly 16 may extend throughyoke 230 via first and second actuation rod channels 246, 248, which maybe seen in the perspective view of yoke 230 in FIG. 12C. A portion ofactuation rod channels 246, 248 may be slotted or grooved and open alongan outer surface of each of arm members 232, 234 to allow actuation rodsto extend past the outer surface during pod manipulation. FIGS. 12D and12E show front and rear end views, respectively, of yoke 230 to providea detail view of actuation rod channels 246, 248 and open region 240.

As mentioned above and as shown in the top view of staplercartridge/yoke assembly 250 in FIG. 13A, each arm member 232, 234 may beparallel to one another and spaced apart to provide clearance forstapler assembly 42 to be advanced therethrough. The arm members 232,234 may function as guide surfaces 252, 254, respectively, to maintainstapler assembly 42 oriented in a predetermined configuration relativeto yoke 230. Furthermore, open region 240 may provide adequate clearancefor stapler assembly 42 to be opened prior to advancement over tissuewhile guide surfaces 252, 254 help to maintain the orientation ofstapler assembly 42 relative to yoke 230 and working body 28.Additionally, as shown in FIG. 13A, clearance slots (open region 240)may function to provide clearance for an endoscope or other tool, thatcan be inserted and advanced or retroflexed to view the working device,as shown below in further detail. To assist in alignment of the staplerassembly 42 to the target tissue, it may be desirable to vary the lengthof the open region 240. As further shown in FIG. 13B, open region 240may be configured with a stop, cover, or extension 256 located adjacentto anvil 253 to constrain any transverse or lateral movement of anvil253 while facilitating movement of cartridge assembly 251.Alternatively, if anvil 253′ is configured to move, stop or extension258 may be configured adjacent to cartridge assembly 251′ to constrainany transverse or lateral movement of cartridge assembly 251′ whilefacilitating movement of anvil 253′, as shown in FIG. 13C.

From the distal end of each arm member 232, 234 of yoke member 230, ahinge member may be connected pivotally and extend distally where it maybe again pivotally connected to a pod member. An alternative angledhinge member 260 may be seen in FIGS. 14A to 14C, which show top, end,and side views, respectively. Angled hinge 260 may have a proximalportion 262 connected to a distal portion 264, which may be angled withrespect to either or both side surface 270 and top surface 272 ofproximal portion 262. A yoke-hinge pivot 266 may be defined at aproximal end of proximal portion 262 for pivotal connection to firstpivot 236 located on yoke 230. Similarly, a hinge-pod pivot 268 may bedefined at a distal end of distal portion 264 for pivotal connection toa pod member. Additionally, actuator rod channel 274 may be optionallydefined along at least a portion of proximal portion 262 to provide aopening or space for placement of an actuator rod. A second hingemember, which may mirror the configuration of angled hinge 260, may beconfigured for connection to second hinge 238 of yoke 230 for connectionto a second pod member. Moreover, angled hinge member 260 may be madefrom any variety of metals or thermoplastics, as described above.

Alternatively, a variation of a yoke/hinge assembly 280 may be utilized,as shown in the top views of FIGS. 15A and 15B. In this variation,yoke/hinge assembly 280 may be configured to flex via one or severaladditional pivots along its length. Additional ramp members 286, 286′,290, 290′, which may be extension members of yoke 282 having pivotedregions at both proximal and distal ends, may be joined via pivots 284,284′, 288, 288′, respectively, to one another to form elongated arms.Hinge members 294, 294′ may be connected via pivots 292, 292′,respectively, to ramp members 290, 290′, respectively, and have pivots296, 296′ located at their distal ends for connection to pod members.

Hinge members 294, 294′ may be actuated to an expanded configuration, asshown in FIG. 15A, and yoke/hinge assembly 280 may also be configured toflex via tensioning members (not shown) positioned within a lumen orslot defined along the length of assembly 280 in one or both arms. Thesetensioning members may be actively manipulated by the user from theirproximal ends. Thus, assembly 280 may be flexed to have a bend radius,as shown in the example of FIG. 15B, to allow access to various regionswithin the hollow body organ as well as to affix various configurationsof tissue. Alternatively, assembly 280 may also be passively flexed bycontact against tissue or via an external device, such as a mandrel, agripping tool, or endoscopes configured to flex the assembly 280. FIG.15C shows an example of a compact configuration of assembly 280 whichmay be utilized for deployment within a body.

FIGS. 16A to 16C show yet another variation on a hinge device which maybe adapted to actively angle the pod assembly in an offsetconfiguration. The working body, as well as vacuum tubes and otherfeatures, have been omitted only for the sake of clarity in these views.FIG. 16A shows a perspective view of offset pod assembly 300 in a“straight” configuration where first pod member 302 and second podmember 304 are in a compact or deployment configuration. FIG. 16B showsan example of offset pod assembly 300 in an expanded configuration wherefirst and second pod members 302, 304, respectively, may be actuated tospread apart from one another. First tensioning member or arm 306 may beseen as being part of first pod member 302 and second tensioning memberor arm 308 may be seen as being part of second pod member 308.

Offset pod assembly 300 also includes variations on first and secondhinge members 310, 312, respectively, which may have respective firstand second actuation slots 322, 324 defined longitudinally along aportion of their respective hinge members 310, 312. First actuationlinkage 314 may be pivotally connected at its distal end to first podmember 302 and pivotally connected to first hinge member 310 at itsproximal end via pivots 318. The proximal end of actuation linkage 314may also be configured to translate within first actuation slot 322 whenurged. Likewise, second actuation linkage 316 may be pivotally connectedat its distal end to second pod member 304 and pivotally connected tosecond hinge member 312 at its proximal end via pivots 320. Also seenare first and second vacuum openings 326, 328, respectively, foracquiring tissue to be approximated, and first and second vacuumpassages 330, 332, respectively.

FIG. 16C shows offset pod assembly 300 having been urged into its offsetconfiguration. As shown, the proximal end of first actuation linkage 314has been translated distally within first actuation slot 322 and theproximal end of second actuation linkage 316 has also been translateddistally within second actuation slot 324. Each linkage 314, 316 may betranslated a distance, d, via actuation rods to rotate first and secondpod members 302, 304 about their respective pivots such that pod members302, 304 may be offset at an angle, a, relative to a longitudinal axisof the working body. From this offset configuration, tissue may beapproximated and affixed at various angles. Alternatively, the podmembers 302, 304 may also be configured to be passively flexed bycontact against tissue or via an external device, including any of thetools described above. Although both pod members 302, 304 are shown inthis illustration as having been offset at similar angles, a single podmember may be alternatively actuated to become offset relative to theother pod member. Furthermore, both pod members may also be offset atvarious angles depending upon the desired tissue configuration;moreover, each pod member may be also independently offset at its ownangle, again depending upon the tissue configuration. These examples aremerely intended to be illustrative and are not intended to be limiting.

The pod assembly itself may be seen in greater detail in the perspectiveview of FIG. 17A. As shown, the pod member may have an elongated vacuumchamber 340. A top cover and an optional basket insert have been removedfor clarity. The vacuum chamber 340 may be in fluid communication viavacuum tubes 200 which may be connected to a vacuum pump (not shown) atits proximal end and to vacuum chamber 340 at its distal end. Tensioningmember or arm 342 may extend longitudinally adjacent to vacuum chamber340 while forming a gap between the two through which the tissue may bedrawn. The tensioning member 342 may extend along the entire length ofthe pod member and beyond or it may extend just partially.Alternatively, in other variations, tensioning member 342 may be omittedentirely. In either case, a distal tip of the tensioning member 342 ispreferably configured to be atraumatic, e.g., blunted, rounded, or itmay have a separate soft tip attached and/or may be shaped or made of amaterial to conform to the distal esophagus and/or proximal stomach toallow ease of insertion and lessen trauma once in place.

A pivot 344 may be configured at the proximal end of the pod member forattachment to a hinge member. The distal end of the pod member may alsohave a tapered flexible tip 346 attached thereto. This tip 346 may beconfigured to have an atraumatic tip 354 to facilitate deployment of thedevice with minimal damage to the tissue. Flexible tip 346 may be madefrom any variety of biocompatible polymers and elastomers. Flexible tip346 may also define a guidewire lumen 348 extending from a distalguidewire opening 350 at atraumatic tip 354 to proximal guidewireopening 352 located proximally on flexible tip 346. As mentioned above,a guidewire may optionally be used to guide the pod members duringinitial deployment and positioning within the hollow body organ in amanner similar to a rapid-exchange (RX) type catheter. Accordingly, anoptional guidewire may be passed through guidewire lumen 348 andsubsequently removed, if desired. A flat mating surface 356 may also bedefined along the side of flexible tip 346 to allow for a compactconfiguration when the second pod member is positioned adjacently. Tip354 may be optionally formed of a radio-opaque material or imbued withradio-opaque capabilities.

A top cover 372 which defines opening 374, as shown in FIG. 17B, may besecured over vacuum chamber 340. An undercut 358 may be defined aroundopening 374 to help aid in mechanically adhering any tissue which may bedrawn into opening 374. Opening 374 is shown as being slotted; however,it may be formed into an elliptical shape or various other shapes solong as an adequate opening is available for adhering a sufficientamount of tissue therewithin or thereto. Alternatively, rather than asingle opening 374, multiple smaller openings may be defined over topcover 372 so long as an adequate area is available for adhering tissuethereto. An optional mesh-like insert may be positioned within vacuumchamber 340 to help prevent the vacuum chamber from becoming clogged bytissue.

Turning to FIGS. 18A to 18D, an optional basket insert 360 is shown inside, end, bottom, and perspective views, respectively. Basket insert360 may be placed within vacuum chamber 340 to provide for an optimizedmesh surface through which a vacuum force may be applied to the tissue.Overall dimensions of basket insert 360 may vary so long as it may besecurely positioned within vacuum chamber 340. An example of insert 360dimensions is 1.3 in. (about 3.3 cm) in length and 0.3 in. (about 0.8cm) in width. Basket insert 360 may also be made from a variety ofmaterials, e.g., stainless steel, provided that the tensile strength issufficient to withstand the various forces generated.

Basket insert 360 may have basket walls 362 forming a mesh-like vacuumchamber 370 with flange 364 surrounding the edges of one open side ofinsert 360. Each of the basket walls 362 may define a plurality ofopenings therethrough and the bottom surface of basket walls 362 mayalso define a plurality of supports 366 positioned in-between openings368. These supports 366 may be configured to space each of the basketwalls 362 away from the walls of vacuum chamber 340, as shown in FIG.17C, which shows a cross-sectional view of basket insert 360 positionedwithin vacuum chamber 340 and top cover 372 placed over the chamber 340.Plenum 376 may thus be defined around the entire basket insert 360, or aportion thereof, between basket walls 362 and vacuum chamber 340 via thespacing provided by supports 366 and flange 364. The open plenum 376allows a vacuum force to be applied to the tissue while preventing thetissue from clogging the vacuum chamber 340.

Alternatively, rather than utilizing a separate basket insert 360 forplacement within vacuum chamber 340, the interior surface of vacuumchamber 340 may be textured, channeled, labyrinthed, or interdigitatedto increase the surface area for vacuum adherence in the same manner asbasket insert 360. Moreover, mechanical tines or teeth may be formedwithin basket insert 360 or within vacuum chamber 340 to facilitateadditional mechanical adherence of tissue within the pod member. Anotheralternative may utilize a snare-like wire or member positioned withinvacuum chamber 340 around opening 374. In such a variation, once tissuehas been drawn through opening 374, the snare may be drawn tightlyaround the adhered tissue.

Moreover, one or both pod members may also incorporate a number of othermethods to facilitate tissue movement and/or adherence to the respectivepod member. For instance, FIGS. 17D and 17E show the top cover 372 andcross-sectional view of basket insert 360, respectively, of FIGS. 17Band 17C with the addition of serrations 341. These serrations 341 areshown as being defined along a length of cover 372; however, they mayalternatively be defined around the opening 374 or in a number ofvarious other configurations depending upon the desired results.Furthermore, serrations 341 are illustrated as protrusions but anyvariations or configurations of serrations 341 may also be utilized inother variations of the device.

FIGS. 19A and 19B show another variation of the pod assembly whereangled pod assembly 380 may be mounted on a distal end of working body382. As shown, first and second pod members 384, 386, respectively, maybe configured to extend angularly via angled hinges 260. Also shown arevacuum tubes 388 extending between pod members 384, 386 and working body382. The figures also show the positioning of staple cartridge 44 andanvil 46 opened for clamping onto folded tissue, which is not shown forclarity. FIGS. 19C and 19D show rear and front views of pod members 384,386 and staple cartridge 44 and anvil 46.

Fixation Assembly

The fixation assembly, as mentioned above, may be delivered through themain lumen of the folder assembly for deployment over tissue which hasbeen approximated into a folded configuration. One variation of astapler which may be used with the folder assembly described herein isdescribed in detail in U.S. Pat. No. 4,610,383 (Rothfuss et al.), whichis incorporated herein by reference in its entirety. Another variationof a stapler assembly 390, which is positioned at the distal end of thefixation assembly, is shown in side views in FIGS. 20A and 20B.Generally, stapler cartridge 392 may be pivotally connected via pivot396 to the end of flexible shaft 398. Anvil 394 may be configured toremain stationary relative to flexible shaft 398 while stapler cartridge392 may be manipulatable into an open and closed configuration withrespect to flexible shaft 398 and anvil 394. As seen, stapler cartridge392 and/or anvil 394 may optionally incorporate a tapered end 411positioned at a distal end of either cartridge 392, anvil 394, or both.Tapered end 411 may be fabricated of any of the polymers or othermaterials described herein and is preferably atraumatic to facilitatedilation or insertion past tissue. To manipulate stapler cartridge 392to open and close, a circular or disk-shaped cam 400 may be pivotallyattached about rotational pivot 402 located on the side of the proximalend of stapler cartridge 392. As seen in the detail view of cam 400 inFIG. 21A, actuation wires or cables 404, 406 may be wound about cam 400such that when cable 404 is pulled, cam 400 is urged to rotate aboutrotational pivot 402 in the direction of arrow 408. Actuation cables404, 406 may be manipulated from their proximal ends by the user. As cam400 is rotated in direction 408, a portion of anvil 394 may be engagedby cam 400 thereby forcing stapler cartridge 392 to pivot into an openconfiguration, as shown in FIG. 20B, when cam 400 is fully rotated, asin FIG. 21B. Cam 400 may be made into other shapes, e.g., oval,elliptical, etc., depending upon the desired design characteristics. Onecam 400 may be utilized, as shown; however, an additional cam may alsobe affixed on the opposite side of stapler cartridge 392 such that dualcams are configured to open and close simultaneously in parallel.Alternatively, in the same device, the location of stapler cartridge 392and anvil 394 may be reversed (e.g. anvil 394 may be configured to movetoward cartridge 392) depending on the location of the desired targetand clearance desired.

Detail views of the stapler assembly is shown in FIGS. 22A to 22D. FIGS.22A to 22C show cross-sectional side, front, and top views,respectively, of stapler assembly 410. Cartridge housing 412 generallyhouses a plurality of staples 414 which may be aligned adjacently to oneanother in one or more rows. The distal ends of both cartridge housing412 and anvil 422 may be configured to be atraumatic, e.g., blunted,rounded, etc., to the tissue to be affixed. Moreover, cartridge housing412 and anvil 422 may be configured such that their cross-sectionalshape is keyed to the main lumen of the folder assembly so that theorientation of the cartridge housing 412 is maintained relative to thefolder assembly, as described above.

FIG. 22C shows a top view of cartridge housing 412 wherein four rows ofstaples 414 may be aligned. Other variations of cartridge housing 412may utilize fewer or greater than four rows of staples 414. To deploystaples 414 from cartridge housing 412, two wedges 416, 416′, which maybe offset or staggered from one another, may each be pulled proximallythrough cartridge housing 412 via staple actuation wire 420. Wedges 416,416′ may be adjacently positioned to one another but are preferablystaggered such that the staples are deployed in a sequenced deploymentorder. Staple actuation wire 420 may be manipulated via its proximal endby the user when staples 414 are to be deployed out of cartridge housing412 into the tissue.

Staples 414 may be deployed through staple apertures 418 defined overthe surface of cartridge housing 412 in apposition to staple closuresurface 424 of anvil 422. As the staggered wedges 416, 416′ are pulledproximally, each wedge 416, 416′ may engage one or more rows of staplesand urge them through staple apertures 418, as shown in FIG. 22A, andthrough the tissue until they are engaged in corresponding stapledetents 426, as shown in FIG. 22D. As further shown in FIG. 22D, whichshows a top view of staple closure surface 424 of anvil 422, each stapledetent 426 preferably corresponds to the distal ends of each staple 414.

As described above, cartridge housing 412 and/or anvil 422 may beconfigured to be atraumatic, e.g., blunted, rounded, etc.; however, itmay be desirable to serrate or otherwise roughen the outside edges ofboth or either the cartridge 412 and/or anvil 422 to ensure full tissuecapture upon clamping of the two surfaces. A variation of the staplerassembly 410 is shown in FIG. 22E, which shows serrations 428 definedalong the lengths of cartridge 412 and anvil 422. Serrations 428 may beoptionally defined along only one of cartridge 412 or anvil 422 and itmay also be defined only partially along the length. Alternatively,other projections or protrusions, such as spears, may be utilized. Inyet another alternative, rather than utilizing projections or serrations428, the surfaces of cartridge 412 and/or anvil 422 in contact with thetissue may simply be roughened or sharpened to facilitate serrating orroughening the contacted tissue or may employ absorptive materials inthe form of pads, coatings or covers to facilitate traction. Such pads,covers or coatings may be formed of cotton, Goretex®, polyester, Velcro,etc., and may remain on the surface of the cartridge once staples aredelivery, or alternatively may be transmitted with the staples to remainwith the tissue affixed thereby.

To facilitate the deployment of the staples 414 as wedges 416, 416′ areurged through cartridge housing 412, staple pushers 430 may be utilized.As shown in FIG. 23A, which is a top view of one variation of staplepushers 430 positioned over corresponding staples 414, a single staplepusher 430 may be configured to engage two staples 414 in adjacent rows.When a wedge contacts a staple pusher 430, two adjacent staples 414 maybe fired sequentially. FIG. 23B shows a detailed perspective view of oneexample of a staple pusher 430. In this variation, staple pusher 430 maybe comprised of one or more sloped cam surfaces 432, 434 for slidinglyengaging a wedge. As a wedge engages a cam surface, it may push staplepusher 430 down towards staples 414 as pusher 430 is guided via one ormore guides 436, 438. Staple pusher 430 may then engage a first staplevia staple engagement surface 440 and a second staple via stapleengagement surface 442. An example of a wedge 446 which may beconfigured to slide within cartridge housing 412 is shown in theperspective view of wedge platform 444 in FIG. 23C. Although a singlewedge 446 is shown in the figure extending from platform 444, two offsetwedges may be configured into a single platform or two individual wedgesmay be utilized adjacent and offset to one another.

As mentioned above, cartridge housing 412 may be manipulated into anopen and closed position for clamping over the tissue. To control theclosure of cartridge housing 412 against anvil 422, a stapler controlhandle may be used, as shown in the cross-sectional views of the staplercontrol in FIGS. 24A and 24B. FIG. 24A shows stapler handle housing 450which may house the tensioning and releasing mechanism for opening andclosing cartridge housing 412 relative to anvil 422. Grip 452 may beprovided for the user to grasp while manipulating the device duringinsertion and deployment as well as to help articulate actuation handle454 for opening and/or closing cartridge housing 412. Actuation handle454 may be pivotally connected to housing 450 via pivot 458 and toactuation linkage 464 via handle pivot 460. When actuation handle 454 ispulled towards grip 452, handle 44 may rotate about pivot 458 and urgeactuation linkage 464 to rotate about handle pivot 460. The opposite endof actuation linkage 464 may be rotatingly connected via pivot 462 to atranslating slide block 466 contained within housing 450. Alternatively,it may be desirable to configure the fixation assembly with the staplejaws preferentially biased in an open position by placing tension onactuation cable 404 with a spring placed in device handle (not shown).Upon insertion of the staple jaws into the main lumen, the jaws may beretained in a closed position by the inner diameter of the main lumen.Upon reaching the yoke portion, the jaws would be adapted to bias openinto clearance slots 254 (252) to slide onto either side of presentedtissue. Once the fixation has occurred, the jaws of the fixationassembly may be directed to a closed position by the yoke, and then thedevice main lumen as the fixation assembly is withdrawn from thepatient.

Slide block 466 may anchor actuation cable 404 thereto via a mechanicalanchor 470, e.g., crimps, clamps, adhesives, etc. An upper surface ofslide block 466 may comprise rack 468 having a plurality of gear teethdefined thereon. When actuation handle 454 is pulled and actuationlinkage 464 is urged proximally, slide block 466 may be forcedproximally within travel guide 480, as indicated by arrow 488, tothereby pull actuation cable 404 proximally and thereby force cam 400 torotate and open the cartridge housing. Simultaneously, while slide block466 is translated proximally, rack 468 may engage and urge gear 484 torotate clockwise in the figure, which in turn may force gear 484 toengage and urge rack 474, which is located on a lower surface ofcomplementary slide block 472, to translate distally within travel guide478, as indicated by arrow 486.

Complementary slide block 472 may anchor actuation cable 406 thereto viaanchor 476 in the same or similar manner as anchor 470. Actuation cable406 may be attached to anchor 476 with a retention spring 482 optionallyinterposed between anchor 476 and slide block 472 to take up any excessslack in the cable 406. FIG. 24B shows the handle assembly afteractuation handle 454 has been actuated and slide blocks 466, 472 havebeen translated within their respective channels 480, 478 to fully orpartially clamp cartridge housing 412 against anvil 422 over the tissue.Once cartridge housing 412 has been clamped over the folded tissue,staple deployment actuator 494 may be rotated or urged to pull stapleactuation wires 420 to fire the staples into the tissue. Once stapledeployment has been completed, actuation handle 454 may be urgeddistally to reverse the process described above to open the clamp forremoval from the tissue region or for repositioning the staple assemblyin another region of the tissue.

The actuation cables 404, 406 as well as staple actuation wires 420 mayeach be routed through flexible shaft 456, which connects handle 450 tostapler assembly 410. Flexible shaft 456 may be comprised of a tubularmember having an outer sheath and an optional inner sheath, either orboth of which may be made from any of the polymeric materials describedabove. The shaft 456 may further utilize braided materials, e.g.,superelastic materials such as Nickel-Titanium alloy, integratedthroughout to increase column strength and to prevent kinking.Alternatively, shaft 456 may be formed of wire (round or square flatconfiguration) to enhance compressive and/or tensile strength.

In a further variation, although the tissue approximation device 500 maybe configured to be flexible, it may also be desirable to actively orpassively curve working body 502 to assist in overall placement of thesystem within the target organ for optimal presentation of tissueoverlap 100 prior to placement of the stapler assembly, as shown in theperspective views of FIGS. 25A and 25B. For passive actuation, a curvedstylet (not shown) may be placed alongside the actuation rods in theactuation rod channels, or in another available space within the workingbody 502, to bias the main body 502 in the curvature provided by thestylet. Working body 502 may be optionally configured to have a bendingregion 504 located proximally of the pod assembly 512. This optionalbending region 504 may be configured to facilitate bending of a portionof the working body 502 in any number of directions or only in aspecified direction, depending upon the desired results.

In addition, as depicted in the detail view of FIG. 25C, a distalposition control 507 may be adapted to fit onto working body 502 via aconnector tube 514. Distal position control 507 may be further adaptedto be integrated into handle 34 (as shown in FIG. 1). Distal positioncontrol 507 may comprise a base 506, a lever 508 configured to rotateabout pivot 510 located on base 506, a linkage mechanism 516, anadjustment assembly 518, and a curvature linkage 519. An optional cap orseal 517 may be placed over a proximal end of the base 506 to seal orcover an opening to the main lumen of the working body. In operation,lever 508 may be pivotally mounted to base 506 via linkage mechanism516. Depending on the amount of curvature desired in bending region 504,adjustment assembly 518 can be adjusted, e.g., by rotating the mechanismto adjust tension curvature linkage 519 prior to actuation of lever 508.FIG. 25A depicts the assembly 500 in the non-deployed, i.e., astraightened position of working body 502, while FIG. 25B depicts fullactuation of lever 508 to impart a curvature to the distal end ofworking body 28. The curvature of bending region 504 may accordingly beadjusted to any intermediate position depending upon the degree ofactuation of lever 508. Furthermore, although the degree of bending ofthe distal portion of the assembly 500 relative to a longitudinal axisof working body 502 is shown to be about 45° in this example, othervariations may be adjusted to have a maximum bend of a lesser or greaterdegree depending upon the desired bending. Moreover, other variationsmay allow for bending of the assembly 500 in either a uni-directionalmanner or in any other direction, again depending upon the desiredresults. It is further contemplated that the bending region 504 mayoccur at a variety of locations along the shaft of working body 502,such as in the distal or proximal region of the working body or at anypoint therebetween.

As mentioned above, optional cap or seal 517 may be placed over aproximal end of the base 506 to seal or cover an opening to the mainlumen of the working body. FIGS. 25D and 25E show perspective and endviews, respectively, of a variation of end cap or seal 517 which may beused to cap the handle of FIG. 25C. End cap 517 may seal the main lumenyet allow passage of devices through the membrane through a smallexpandable opening 523 covering the main lumen. An optional tab orhandle 521 may extend from the cap or seal 517 to facilitate handling ofthe cover. The cap or seal 517 may be formed from any of the polymericmaterials described herein, e.g., silicone.

FIG. 26 shows a variation 520 of how the tissue approximation assemblymay be utilized with other devices such as an endoscope 522. In thisexample, clearance slots (open region 240) may function to provideclearance for an endoscope 522, or other tool, that can be inserted intoand advanced through the main lumen 40 of working body 28. During tissueapproximation, endoscope 522 may be advanced distally out of main lumen40 and advanced past pod assembly 16. A bending region 524 of endoscope522 may then be retroflexed to view the results or progress of thetissue approximation and/or fixation using an imaging system 526, e.g.,optical fibers, CCD or CMOS imaging system, etc., positioned within adistal end of the endoscope 522.

FIG. 27 shows a portion of flexible shaft 456 of the fixation assemblyinserted through main lumen 40 of handle 110 in assembly 490. Handle 110is partially shown for clarity. As mentioned above, one or severalinsertion indicators 492 may be defined along a portion of flexibleshaft 456 at predetermined positions. These indicators are preferablylocated near a proximal end of shaft 456 to indicate information to theuser. For instance, when shaft 456 is aligned against handle 110 at oneparticular indicator, this may notify the user when it is safe forstapler assembly 410 to be opened in a patient body, e.g., whencartridge housing 412 is positioned proximally of the tissue between theyoke members. A second indicator defined along shaft 456 may indicate tothe user when the second indicator is aligned against handle 110 that itis safe to clamp stapler assembly 410 over the tissue, e.g., whenstapler assembly 410 is positioned fully over the approximated andfolded tissue thereby indicating that the cartridge housing 412 may beclamped against anvil 422 and the tissue for staple deployment.Additional indicators may be defined along shaft 456 to indicate variousother information, e.g., positional information such as how deep staplerassembly has been inserted relative to the folder assembly. Theseexamples are merely intended to be illustrative and are not limiting inhow indicators defined along the shaft 456 may be utilized.

Once the tissue has been affixed, stapler assembly 410 may be removedfrom the main lumen of the folder assembly and an endoscopic device maybe optionally inserted within the main lumen. The endoscopic device maybe outfitted with a visual imaging system, e.g., fiberoptic, CCD, CMOS,etc., to view the tissue region. If necessary, stapler assembly 410, orsome other tool, may be subsequently inserted through the main lumen toperform additional aspects of the procedure, or to complete theprocedure with the placement of additional fixation elements.

In describing the system and its components, certain terms have beenused for understanding, brevity, and clarity. They are primarily usedfor descriptive purposes and are intended to be used broadly andconstrued in the same manner. Having now described the invention and itsmethod of use, it should be appreciated that reasonable mechanical andoperational equivalents would be apparent to those skilled in this art.Those variations are considered to be within the equivalence of theclaims appended to the specification.

1. A tissue acquisition and fixation system comprising: a tissueacquisition device having an elongate main body defining a main lumentherethrough, wherein a distal end of the acquisition device is adaptedto acquire tissue from within a hollow body organ and reconfigure thetissue into at least one overlap region; and a tissue fixation devicehaving an articulatable cartridge assembly adapted to be advancedthrough the main lumen while maintaining a fixed orientation relative tothe main lumen.
 2. The system of claim 1 wherein the tissue acquisitiondevice further comprises at least two opposing members longitudinallypositioned relative to one another at a distal end of the main lumensuch that the cartridge assembly is stabilized from lateral movementbetween the at least two opposing members.
 3. The system of claim 1wherein the tissue fixation device comprises a flexible shaft connectedto the cartridge assembly, the flexible shaft having at least oneindicator defined thereon for alignment with the acquisition device,wherein a position of the indicator relative to the acquisition devicecorresponds to a predetermined position of the cartridge assemblyrelative to the main body.
 4. The system of claim 3 wherein the flexibleshaft defines at least a second indicator thereon spaced apart relativeto the at least one indicator.
 5. The system of claim 3 wherein thetissue acquisition device comprises a complementary indicator thereonfor corresponding alignment with the at least one indicator, whereinalignment of each indicator is indicative of when cartridge assembly isactuatable.
 6. The system of claim 1 wherein the tissue acquisitiondevice further comprises at least a first acquisition member positionedat the distal end of the acquisition device.
 7. The system of claim 6wherein the first acquisition member is articulatable via an actuationrod disposed along a length of the main body, wherein the actuation rodis manipulatable via its proximal end.
 8. The system of claim 7 furthercomprising an actuation rod tubing through which the actuation rod isslidably positionable.
 9. The system of claim 8 wherein a distal end ofthe actuation rod tubing is adapted to terminate proximally of a distalend of the actuation rod, wherein the actuation rod tubing is attachednear or at a distal end of the main body.
 10. The system of claim 1wherein the tissue acquisition device comprises at least a firstacquisition member and a second acquisition member each positionablecorrespondingly in apposition to one another at the distal end.
 11. Thesystem of claim 10 wherein the first acquisition member and the secondacquisition member are each articulatable via a corresponding actuationrod disposed along a length of the main body, wherein each actuation rodis manipulatable via its proximal end.
 12. The system of claim 10wherein the first acquisition member and the second acquisition memberare each individually articulatable from a first delivery configurationto a second expanded configuration.
 13. The system of claim 10 whereinthe first acquisition member and the second acquisition member aresimultaneously articulatable from a first delivery configuration to asecond expanded configuration.
 14. The system of claim 10 wherein thefirst acquisition member and the second acquisition member each defineat least one opening adapted to adhere tissue thereto via a vacuum,wherein each opening is positionable to be in offset apposition to oneanother.
 15. The system of claim 14 further comprising at least onevacuum tubing positioned along at least a portion of the main body,wherein the vacuum tubing is adapted to maintain fluid communicationthrough the opening.
 16. The system of claim 14 further comprising atleast one meshed basket positioned within at least one of theacquisition members.
 17. The system of claim 10 wherein the firstacquisition member and the second acquisition member each comprise atensioning member adapted to be positioned adjacent to an opposingacquisition member.
 18. The system of claim 10 further comprising afirst hinge member and a second hinge member each pivotally connecting acorresponding acquisition member to the main body.
 19. The system ofclaim 18 wherein at least one hinge member is angled relative to itscorresponding acquisition member.
 20. The system of claim 10 wherein thefirst and the second acquisition members are each adapted to rotate intoan offset configuration such that each of the acquisition members areangled relative to a longitudinal axis defined by the main body.
 21. Thesystem of claim 1 further comprising a guidewire for positioning thedistal end of the acquisition device.
 22. The system of claim 1 whereinthe tissue acquisition device further comprises an atraumatic distaltip.
 23. The system of claim 22 wherein the distal tip is tapered. 24.The system of claim 22 wherein the distal tip is comprised of apolymeric material.
 25. The system of claim 22 wherein the distal tipdefines a guidewire lumen therethrough.
 26. The system of claim 1wherein the elongate main body of the tissue acquisition device isconfigured to be curved.
 27. The system of claim 26 wherein the elongatemain body is actively or passively curved.
 28. The system of claim 27wherein the elongate main body is passively curvable via a curved styletremovably insertable within the main body.
 29. The system of claim 27wherein the elongate main body is actively curvable via a proximallylocated position control.
 30. The system of claim 26 wherein theelongate main body defines at least one bending region.
 31. The systemof claim 26 wherein the elongate main body is adapted to beuni-directionally curved.
 32. The system of claim 26 wherein theelongate main body is adapted to be curved in a plurality of directions.33. The system of claim 1 further comprising a handle connected to aproximal end of the main body.
 34. The system of claim 33 wherein thehandle further comprises at least one actuation mechanism adapted toarticulate the distal end of the acquisition device.
 35. The system ofclaim 33 wherein the handle further comprises a gasket adapted toprevent fluid communication through an interior of the handle when thetissue fixation device is positioned therethrough.
 36. The system ofclaim 1 wherein the main body is comprised of a plurality of adjacentlinks through which the main lumen is defined.
 37. The system of claim36 wherein at least a majority of the links are adapted to pivot withrespect to the adjacent link.
 38. The system of claim 2 wherein each ofthe two opposing members are adapted to flex via a plurality of pivots.39. The system of claim 1 wherein the tissue fixation device comprises ahandle connected to the cartridge assembly via a flexible shaft.
 40. Thesystem of claim 39 wherein the handle is adapted to articulate thecartridge assembly from a clamped configuration to an openconfiguration.
 41. The system of claim 40 wherein the handle is furtheradapted to deploy a plurality of staples from the cartridge assembly.42. The system of claim 1 wherein the cartridge assembly comprises astapler housing and an anvil in apposition to the stapler housing. 43.The system of claim 42 wherein the stapler housing is adapted to rotateabout a pivot relative to the anvil from a clamped configuration to anopen configuration.
 44. The system of claim 43 wherein the cartridgeassembly further comprises at least one cam eccentrically connected tothe stapler housing such that rotation of the cam urges the staplerhousing to rotate about the pivot.
 45. The system of claim 44 furthercomprising at least one actuation cable adapted to wind about and rotatethe cam via manipulation of a proximal end of the actuation cable. 46.The system of claim 42 wherein the anvil is adapted to rotate about apivot relative to the stapler housing from a clamped configuration to anopen configuration.
 47. The system of claim 42 further comprising aplurality of staples positionable within the stapler housing.
 48. Thesystem of claim 42 further comprising at least one wedge adapted to betranslated with the stapler housing for deploying staples throughcorresponding apertures defined in the stapler housing.
 49. The systemof claim 42 further comprising at least one staple pusher adapted to behoused within the stapler housing for contact against staples.
 50. Amethod of acquiring and affixing tissue from within a hollow body organ,comprising: positioning a distal end of an elongate main body within thehollow body organ such that a first and a second acquisition member eachpositioned at the distal end are adjacent to at least one region oftissue to be acquired; acquiring the at least one region of tissue viaat least the first acquisition member; articulating at least the firstacquisition member such that the acquired tissue is approximated incontact with a tensioning member to form a folded region of tissue; andaffixing the folded region of tissue via a cartridge assembly which isadapted to maintain a predetermined orientation relative to a main lumendefined through the elongate main body.
 51. The method of claim 50wherein positioning the distal end of the elongate main body comprisesadvancing at least one acquisition member transorally.
 52. The method ofclaim 50 wherein acquiring the at least one region of tissue comprisesacquiring tissue from at least two apposed regions of tissue.
 53. Themethod of claim 50 wherein acquiring the at least one region of tissuecomprises adhering the tissue to at least the first acquisition membervia a vacuum created in the first acquisition member.
 54. The method ofclaim 50 wherein acquiring the at least one region of tissue furthercomprises acquiring a second region of tissue via a second acquisitionmember.
 55. The method of claim 54 wherein articulating at least thefirst acquisition member comprises articulating both the firstacquisition member and the second acquisition member relative to oneanother such that acquired tissue is approximated between eachacquisition member and corresponding tensioning members to create thefolded region of tissue.
 56. The method of claim 55 wherein the firstacquisition member and the second acquisition member are articulatedsimultaneously.
 57. The method of claim 55 wherein the first acquisitionmember and the second acquisition member are articulated sequentially.58. The method of claim 50 further comprising advancing the cartridgeassembly through the main lumen prior to affixing the folded region oftissue, wherein the cartridge assembly cross-sectional shape is keyed toa cross-sectional area of the main lumen.
 59. The method of claim 50further comprising laterally stabilizing the cartridge assembly via ayoke member positioned at the distal end of the elongate main body priorto affixing the folded region of tissue.
 60. The method of claim 50further comprising advancing the cartridge assembly through the mainlumen until an indicator which is defined along a flexible shaftattached to the cartridge assembly is aligned with a correspondingindicator defined proximally of the main lumen.
 61. The method of claim50 wherein affixing the overlap region of tissue comprises deploying aplurality of staples from the cartridge assembly into the folded regionof tissue.
 62. The method of claim 61 wherein deploying the plurality ofstaples comprises translating at least one wedge positioned within thecartridge assembly, wherein the wedge is adapted to contact and urge theplurality of staples into the folded region of tissue.
 63. The method ofclaim 50 further comprising removing the cartridge assembly from themain lumen and inspecting the folded region of tissue via an endoscopicimaging device advanced through the main lumen.
 64. The method of claim50 further comprising advancing an endoscopic imaging device through themain lumen and inspecting the folded region of tissue prior to affixingthe folded region of tissue.
 65. The method of claim 50 furthercomprising removing the elongate main body from the region of tissue.66. A method of manipulating tissue from within a hollow body organ,comprising: positioning a distal end of an elongate main body whichdefines a main lumen therethrough within the hollow body organ such thata first and a second acquisition member each positioned at the distalend are adjacent to at least one region of tissue to be acquired,wherein the main lumen is adapted to orient a cartridge assembly forpassage therethrough; acquiring the at least one region of tissue via atleast the first acquisition member; and approximating the at least oneregion of tissue while maintaining the region of tissue to the firstacquisition member.
 67. The method of claim 66 wherein positioning thedistal end of the elongate main body comprises advancing at least oneacquisition member transorally.
 68. The method of claim 66 whereinacquiring the at least one region of tissue comprises adhering thetissue to at least the first acquisition member via a vacuum created inthe first acquisition member.
 69. The method of claim 66 whereinapproximating the at least one region of tissue comprises passivelyarticulating at least one portion of the main body.
 70. The method ofclaim 69 wherein passively articulating comprises removably inserting acurved stylet within a length of the main body.
 71. The method of claim66 wherein approximating the at least one region of tissue comprisesactively articulating at least one portion of the main body.
 72. Themethod of claim 71 wherein actively articulating comprises manipulatingthe at least one portion of the main body via a proximally locatedposition control.
 73. The method of claim 72 wherein manipulating the atleast one portion comprises uni-directionally curving the at least oneportion of the main body.
 74. The method of claim 72 whereinmanipulating the at least one portion comprises curving the at least oneportion of the main body in a plurality of directions.
 75. The method ofclaim 71 further comprising articulating at least the first acquisitionmember such that the acquired tissue is approximated in contact with atensioning member to form a folded region of tissue.
 76. The method ofclaim 75 further comprising affixing the folded region of tissue via thecartridge assembly which is adapted to maintain a predeterminedorientation relative to a main lumen defined through the elongate mainbody.
 77. The method of claim 75 further comprising acquiring a secondregion of tissue via the second acquisition member.
 78. The method ofclaim 77 further comprising articulating the second acquisition membersuch that the acquired tissue is approximated in contact with a secondtensioning member to form a second folded region of tissue.